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NCT06767683
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Conditions: Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 786
Sponsor: Alkermes, Inc.
Location: Alkermes Investigational Site Cullman Alabama
Summary
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.
Eligibility Criteria
Inclusion Criteria:
* Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3), ALKS 2680-302 (Brilliance NT1) , ALKS 2680-303 (Brilliance NT2) , ALKS 2680-304 (Brilliance NT 1)
* Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)
Exclusion Criteria:
* Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study
* Is currently pregnant, breastfeeding, or planning to become pregnant during the study
* Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening
Source: ClinicalTrials.gov (NCT06767683). StuddyBuddy aggregates publicly available trial information.